Overview
This FDA guidance finalizes the action level for inorganic arsenic in rice cereals for infants. It is the guidance document itself, distinct from Supporting Document for Action Level for Inorganic Arsenic in Rice Cereals for Infants, which contains the supporting achievability and risk tables.
Key numbers
| Parameter | Source value |
|---|---|
| Action level | 100 microgram per kilogram (µg/kg), or 100 parts per billion (ppb) |
| Analyte | Inorganic arsenic |
| Matrix | Rice cereals for infants |
| Scope | All types of infant rice cereals, including white-rice, brown-rice, organically grown, and conventionally grown |
| Docket | FDA-2016-D-1099 |
| Guidance date | August 2020 |
| Legal posture | FDA guidance, nonbinding recommendation |
FDA states that it intends to analyze infant rice cereal samples for total arsenic and to speciate samples containing more than 100 µg/kg or 100 ppb total arsenic to determine inorganic arsenic levels. The guidance says FDA considers the 100 µg/kg action level an important source of information for determining whether infant rice cereal is adulterated within the meaning of section 402(a)(1) of the FD&C Act.
The guidance’s NHANES/WWEIA intake footnote reports mean per-capita daily dry instant infant-cereal intake during the first year of life as rice 4.8 g/day, oatmeal 2.8 g/day, barley 0.1 g/day, and mixed grains 0.8 g/day for cereals not containing fruit.
Methods (brief)
This is a nonbinding FDA guidance, not a sampling report. The guidance relies on FDA’s arsenic-in-rice risk assessment and supporting document. It states that the method used by FDA for analyzing inorganic arsenic in rice was posted separately on FDA’s website.
Implications
Certification: The source is a U.S. federal policy comparator for iAs in infant rice cereal and does not set HMTc thresholds.
Courses: The source cleanly distinguishes action levels from tolerances or rulemaking limits under 21 CFR 109.4 and 109.6.
App: The source supports a U.S. regulatory-context label for infant rice cereal.
Microbiome: No direct microbiome endpoint.
Related evidence
- FDA Closer to Zero — 100 ppb Inorganic Arsenic Action Level for Infant Rice Cereal
- FDA Closer to Zero — Program Overview
- Baby Cereals / Grain Products, Dry (Rice-Based)
Verification notes
- Ingested from the archived source file on 2026-08-03.
- The 100 µg/kg / 100 ppb value, speciation screening rule, scope phrase, and intake footnote were checked against the PDF text twice during ingest.
Update history
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